Clinical Documentation Specialist II
The Fountain Group
The Fountain Group is currently seeking a Clinical Documentation Specialist II for a prominent client of ours. This position is located in Lake County, North Chicago, IL . Details for the position are as follows:
Job Title: Clinical Documentation Specialist IILocation: Lake County, North Chicago, IL - Hybrid Preferred
Pay Rate: $41-$38/hr
Duration: 1 year Job Description
- Manage and maintain Trial Master File (TMF) documentation to ensure inspection readiness and compliance with ICH GCP requirements.
- Perform TMF quality checks and monitor completeness, accuracy, timeliness, and document quality throughout clinical trial lifecycles.
- Partner with document owners and cross-functional study teams to resolve filing and documentation quality issues.
- Monitor TMF health metrics, identify trends and risks, and implement mitigation strategies.
- Prepare TMF oversight reports, quality assessment reports, presentations, and stakeholder updates.
- Support finalization and archival of study Master Files within electronic TMF systems.
- Support audit and regulatory inspection preparation activities.
- Review SOPs, work instructions, and job aids and contribute to process improvement initiatives.
- Perform QC checks on internal and external document processing activities.
- Bachelor's degree or international equivalent preferred.
- 4+ years of relevant clinical document management or equivalent clinical research experience.
- Without a bachelor's degree, 6+ years of relevant clinical research experience.
- Clinical document management and Trial Master File (TMF) experience.
- Electronic Trial Master File (eTMF) systems.
- ICH GCP and clinical documentation processes.
- TMF quality control and inspection-readiness activities.
- TMF health metrics, oversight, and quality assessments.
- Clinical documentation gap identification and issue resolution.
- Microsoft Excel and PowerPoint.
- Experience supporting clinical audits and regulatory inspections.
- Experience developing SOPs, work instructions, and job aids.
- Experience with TMF process improvement initiatives.
- Experience conducting QC reviews of clinical documentation.
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Vacancy posted 1 day ago
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